Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 Monotherapy
Atebimetinib · 2 trials · 11 indications
The OS of participants with atebimetinib in combination with mGnP versus GnP
Number of participants with adverse events
Number of participants with dose-limiting toxicities
Selection of candidate optimal dose to take forward into Ph2a
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
| Arm | Type | Description |
|---|---|---|
| Atebimetinib + mGnP | EXPERIMENTAL | Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
| GnP | ACTIVE_COMPARATOR | Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
| IMM-1-104 monotherapy (Treatment Group A) | EXPERIMENTAL | IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer |
| IMM-1-104 in combination with mGnP (Treatment Group B) | EXPERIMENTAL | IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma |
| IMM-1-104 in combination with mFFX (Treatment Group C) | EXPERIMENTAL | IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma |
| IMM-1-104 in combination with dabrafenib (Treatment Group D) | EXPERIMENTAL | IMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation |
| IMM-1-104 in combination with pembrolizumab (Treatment Group E) | EXPERIMENTAL | IMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma |
| Name | Type | Description |
|---|---|---|
| Atebimetinib | DRUG | Once daily oral tablets |
| GnP | DRUG | Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion |
| mGnP | DRUG | Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel) |
| IMM-1-104 Monotherapy (Treatment Group A) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met |
| IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of gemcitabine and nab-paclitaxel until treatment discontinuation criteria are met. Gemcitabine will be administered at a dose of 1000 mg/m\^2 nab-Paclitaxel will be administered at a dose of 125 mg/m\^2 |
| IMM-1-104 + modified FOLFIRINOX (Treatment Group C) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of modified FOLFIRNOX until treatment discontinuation criteria are met. FOLFIRINOX will be administered as follows: Folinic Acid will be administered at 400 mg/m\^2 Fluorouracil will be administered at 2400 mg/m\^2 Irinotecan will be administered at 150 mg/m\^2 Oxaliplatin will be administered at 85 mg/m\^2 |
| IMM-1-104 + dabrafenib (Treatment Group D) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily). |
| IMM-1-104 + pembrolizumab (Treatment Group E) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg. |
Inclusion Criteria: * Must be ≥18 years of age * Must have confirmed diagnosis according to AJCC staging as follows: * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must be treatment...
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Atebimetinib is an investigational small molecule kinase inhibitor being developed by Immuneering Corporation for advanced solid tumors and pancreatic cancer. It is designed to target MEK, a kinase in the MAPK signaling pathway. Atebimetinib is being studied both as a monotherapy and in combination with other agents in clinical trials.
Atebimetinib targets MEK, a kinase in the MAPK signaling pathway. It belongs to the -tinib kinase inhibitor class and is a small molecule. By inhibiting MEK, atebimetinib is designed to interfere with signaling that drives tumor cell proliferation in cancers such as advanced solid tumors and pancreatic ductal adenocarcinoma.
Atebimetinib is being developed by Immuneering Corporation, which trades under the ticker IMRX. The company is advancing the drug as a monotherapy and in combination regimens, including a first-line study pairing it with gemcitabine and nab-paclitaxel in metastatic pancreatic adenocarcinoma.
Atebimetinib is in clinical development, with a Phase 1/2a study in advanced or metastatic solid tumors and a Phase 3 study in metastatic pancreatic adenocarcinoma. It is investigational and is not described as FDA approved. The Phase 3 trial is currently recruiting participants across the United States, Europe, and Australia.
Atebimetinib is being studied in two registered trials. NCT05585320 is a Phase 1/2a study in advanced or metastatic solid tumors, including pancreatic adenocarcinoma, melanoma, and non-small cell lung cancer, and is active but not recruiting. NCT07562152 is a recruiting Phase 3 trial of atebimetinib plus gemcitabine and nab-paclitaxel as first-line treatment in metastatic pancreatic adenocarcinoma.
Yes, atebimetinib is also known as IMM-1-104. The names refer to the same MEK-targeting small molecule from Immuneering Corporation. IMM-1-104 Monotherapy, sometimes labeled Treatment Group A, describes the monotherapy arm of the clinical program testing this compound in advanced solid tumors and pancreatic cancer.